Assessment of Noninvasive Neuromodulation in a Group of Traumatic Brain Injured Patients and Healthy Volunteers

NCT07373366 | Recruiting Phase 2

• 1 other identifier: 84791824.8.0000.0068
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Severe traumatic brain injury, particularly diffuse axonal injury (DAI), often leads to lasting neurological issues. Cerebral dysfunction in DAI can be evaluated by monitoring cerebral electrical activity (CEA) through EEG. The radio electric asymmetric conveyer (REAC) is a noninvasive method designed to rebalance cellular polarity via endogenous bioelectric fields and modulate CEA. This technique may alter CEA, which can be detected using quantitative EEG (qEEG). Objective: To assess qEEG changes following DAI and brain wave alterations after a REAC protocol in this group. Methods: In this prospective, randomized, double-blind clinical trial, DAI patients will be assigned to active or sham groups for 19 sessions of either true or sham REAC following ICU discharge. Interventions include one Neuro Postural Optimization session and 18 NPPO-BWO-G sessions (up to four per day). The main outcome is to evaluate changes in qEEG patterns through population brain electrical mapping after REAC therapies.

Conditions

Traumatic Brain Injury

Keywords

TRAUMATIC BRAIN INJURY; DIFFUSE AXONAL INJURY; NEUROMODULATION; RADIOELECTRIC ASSIMETRIC CONVEYER

Outcome Measures

Primary Outcomes (1)

• Observe if there are significant changes in the electroencephalographic pattern, compared between the groups.

  Six months

Secondary Outcomes (2)

• Observe if there are significant clinical improvement determined by the modified Rankin scale between the groups.

  six months

• Observe if there are significant clinical improvement determined by the Glasgow outcome scale between the groups.

  Six months

Study Arms (2)

ACTIVE

ACTIVE COMPARATOR

Subjects undergoing active therapy

Device: Subjects in the intervention group receive low-frequency radioelectric therapy

SHAM

SHAM COMPARATOR

Subjects receiving sham therapy

Device: Sham, the device simulates a therapy session

Interventions

Subjects in the intervention group receive low-frequency radioelectric therapy DEVICE

The intervention is based on two treatment protocols, the neuro-postural optimization in single aplication and brain-waves optimization in 18 sessions. This protocol is exclusive for the present study.

ACTIVE

Sham, the device simulates a therapy session DEVICE

The device simulates a therapy session

SHAM

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• DAI diagnostic and consent for participation with the next of kin for each eligible patient

You may not qualify if:

• Open TBI
• History of chronic neurological conditions

Sponsors & Collaborators

• University of Sao Paulo: lead
• Istituto Rinaldi Fontana: collaborator

Study Sites (1)

Hospital das Clínicas da FM-USP

São Paulo, São Paulo, 05.403-905, Brazil

RECRUITING

Related Publications (11)

• Rinaldi S, Mura M, Castagna A, Fontani V. (2014) Long-lasting changes in brain activation induced by a single REAC technology pulse in Wi-Fi bands. Randomized double-blind fMRI qualitative study. Sci Rep 4:5668. https://doi.org/10.1038/srep05668

  BACKGROUND

• Castagna A, Rinaldi S, Fontani V, Aravagli L, Mannu P, Margotti ML. (2010) Does osteoarthritis of the knee also have a psychogenic component? Psycho-emotional treatment with a radio-electric device vs. intra-articular injection of sodium hyaluronate: an open-label, naturalistic study. Acupunct Electrother Res 35:1-16. https://doi.org/10.3727/036012910803860968

  BACKGROUND

• Li S, Zaninotto AL, Neville IS, Paiva WS, Nunn D, Fregni F. (2015) Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. Neuropsychiatr Dis Treat 11:1573-1586. https://doi.org/10.2147/NDT.S65816

  BACKGROUND

• Zaninotto AL, Vicentini JE, Solla DJ, Silva TT, Guirado VM, Feltrin F, de Lucia MC, Teixeira MJ, Paiva WS. (2017) Visuospatial memory improvement in patients with diffuse axonal injury (DAI): a 1-year follow-up study. Acta Neuropsychiatr 29:35-42. https://doi.org/10.1017/neu.2016.29

  BACKGROUND

• Rinaldi C, Landre CB, Volpe MI, Goncalves RG, Nunes LDS, Darienso D, Cruz AV, Oliveira JD, Rinaldi S, Fontani V, Barcessat AR. Improving Functional Capacity and Quality of Life in Parkinson's Disease Patients through REAC Neuromodulation Treatments for Mood and Behavioral Disorders. J Pers Med. 2023 Jun 1;13(6):937. doi: 10.3390/jpm13060937.

  PMID: 37373926 BACKGROUND

• Goncalves de Oliveira Cruz AV, Goes Goncalves R, Nunes L, Douglas Quaresma de Oliveira J, Lima Monteiro ES, Soares Eneias I, Guilherme Lima TC, Duarte Ferreira L, Souza Neri E, da Cunha Pena JL, Celis de Cardenas AM, Cortes Volpe MI, Filgueiras de Assis Melo MV, Rinaldi A, Pinheiro Barcessat AR. (2022) Neuro Postural Optimization Neuromodulation Treatment of Radio Electric Asymmetric Conveyer Technology on Stress and Quality of Life in Institutionalized Children in a Capital City of the Brazilian Amazon. Cureus 14:e26550. https://doi.org/10.7759/cureus.26550

  BACKGROUND

• Pinheiro Barcessat AR, Nolli Bittencourt M, Duarte Ferreira L, de Souza Neri E, Coelho Pereira JA, Bechelli F, Rinaldi A. (2020) REAC Cervicobrachial Neuromodulation Treatment of Depression, Anxiety, and Stress During the COVID-19 Pandemic. Psychol Res Behav Manag 13:929-937. https://doi.org/10.2147/PRBM.S275730

  BACKGROUND

• Rinaldi A, Rinaldi C, Coelho Pereira JA, Lotti Margotti M, Bittencourt MN, Barcessat ARP, Fontani V, Rinaldi S. (2019) Radio electric asymmetric conveyer neuromodulation in depression, anxiety, and stress. Neuropsychiatr Dis Treat 15:469-480. https://doi.org/10.2147/NDT.S195466

  BACKGROUND

• Gennarelli TA, Spielman GM, Langfitt TW, Gildenberg PL, Harrington T, Jane JA, Marshall LF, Miller JD, Pitts LH. (1982) Influence of the type of intracranial lesion on outcome from severe head injury. J Neurosurg 56:26-32. https://doi.org/10.3171/jns.1982.56.1.0026

  BACKGROUND

• de Almeida CE, de Sousa Filho JL, Dourado JC, Gontijo PA, Dellaretti MA, Costa BS. (2016) Traumatic Brain Injury Epidemiology in Brazil. World Neurosurg 87:540-547. https://doi.org/10.1016/j.wneu.2015.10.020

  BACKGROUND

• Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.

  PMID: 18162698 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Diffuse Axonal Injury

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Injuries, Diffuse

Central Study Contacts

Sérgio Brasil, MD. PhD.

CONTACT

+5511981210990; sbrasil@alumni.usp.br

Alessandra C Renck, MD. PhD.

CONTACT

+5511981211114; alerenck@alumni.usp.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD. PhD.

Model Details: Patient selection Medical record, radiology, participation consent Step 1 (pre-intervention) qEEG, TCD and brain4care up to 3 days before the start of REAC sessions Step 2 (intervention) NPO neuromodulation (single session) Step 3 (intervention) NPPO-GW neuromodulation (18 sessions) Step 4 (post-intervention) qEEG, TCD and brain4care up to 3 days after the end of REAC sessions Follow-up discharge, 3m and 6m - mRankin, GOSE, DASS 21

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: January 28, 2026
• Study Start: April 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)